1) Physicochemical Properties of the Drug
Sensitivity to light, moisture, oxygen, or pH changes.
Tendency for adsorption or absorption onto the packaging material.
2) Product Formulation
Liquid, semi-solid, or solid forms.
Sterility requirements (e.g., injectables).
Volatility or reactivity of ingredients.
3) Route of Administration
Parenteral products (injections) demand the highest level of packaging integrity (e.g., Type I glass vials).
Oral solids require protection primarily from moisture and oxygen.
4) Compatibility and Safety
Risk of leachables or extractables from plastic or metal.
Potential for product contamination or degradation.
5) Shelf Life and Stability Requirements
Products with a longer shelf life need more robust barrier properties.
Influence of temperature fluctuations during transportation or storage.
6) Regulatory and Legal Constraints
Must meet pharmacopoeial standards (e.g., USP, EP) and FDA/EMA guidelines.
Child-resistant and tamper-evident requirements for certain products.
7) Cost and Convenience
Manufacturing feasibility, recycling, and consumer convenience (e.g., lightweight packaging).
8) Environmental Considerations
Sustainability, recyclability, and carbon footprint.
Reduced reliance on non-renewable resources.